Malaria Clinical Trial
— LAMPREGOfficial title:
"LAMPREG TRIAL" Active Case Detection and Treatment of Malaria in Pregnancy Using LAMP Technology: A Pragmatic Randomized Multi-Center Diagnostic Outcomes Trial
Objective: The aim of this study is to evaluate the impact of enhanced malaria cases detection using molecular testing (LAMP) on maternal and infant morbidity and mortality in a prospective study design. A pragmatic randomized control diagnostic trial will be conducted from October 2020 until March 1 2022 in pregnant mothers at sites in Ethiopia. Both symptomatic and asymptomatic first and early second trimester pregnant women will be included in the study and individually randomized to either standard of care or enhanced cased detection arms using LAMP for malaria. Women (n=2583) will be enrolled during a seven-month period encompassing the peak transmission seasons and then followed until delivery. In the standard of care arm, venous blood sample will be collected from each study participant and the presence of Plasmodium infection will be diagnosed by microscopy in symptomatic patients. Pregnant women who test positive for malaria will be referred and treated for malaria with quinine or artemisinin combination therapies (ACTs) as per national guidelines. In the intervention arm, mothers who are symptomatic or asymptomatic will be tested by a commercially available CE-approved LAMP malaria test and microscopy/RDT for malaria at each clinic visit and treated if positive by any test. Pregnant mothers who require treatment will be referred and treated with either quinine or artemisinin combination therapy (ACTs) as per national guidelines. The primary outcome is the proportion of deliveries with low birth weight based on WHO definition, with secondary outcomes of:(i)absolute birth weight; (ii) maternal hemoglobin;(ii) neonatal hemoglobin at birth;(iv) neonatal mortality; (v) stillbirth; and (vi) prematurity in each arm of the study.
Status | Recruiting |
Enrollment | 2583 |
Est. completion date | December 31, 2023 |
Est. primary completion date | August 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Must be a pregnant woman in the first or second trimester at time of enrollment - Consent to the study Exclusion Criteria: - Pregnant woman in the third trimester at time of enrollment - Multiparity - Severe malaria at inclusion as per WHO criteria - At risk pregnancy as per Ethiopian guidelines - Impossibility to date pregnancy |
Country | Name | City | State |
---|---|---|---|
Canada | University of Calgary | Calgary | Alberta |
Ethiopia | Armauer Hansen Research Institute, Ethiopia | Addis Ababa | |
Ethiopia | Amhara Public Health Institute | Bahir Dar | Amhara |
Ethiopia | Tropical & Infectious Diseases Research Center (TIDRC), Jimma University | Jimma | Oromia |
Lead Sponsor | Collaborator |
---|---|
University of Calgary | Amhara Public Health Institute, Ethiopia, Armauer Hansen Research Institute, Ethiopia, Jimma University |
Canada, Ethiopia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Performance of diagnosis methods compared to qRT-PCR as a gold standard | Evaluation of the sensitivity, specificity, PPV and NPV for LAMP, RDT and microscopy in the study | At the end of the study | |
Other | Assessment of the development of placental malaria | Evaluation of the presence of malaria pigment in macrophages from placental blood. qPCR in placenta blood | At delivery and post hoc | |
Primary | Proportion of deliveries with low birth weight | Birth weight will be considered as low if < 2500 g | At the head to toe assessment of the baby within 24 hours of delivery | |
Secondary | Absolute birth weight | Birth weight in grams | At the head to toe assessment of the baby within 24 hours of delivery | |
Secondary | Maternal hemoglobin | Maternal hemoglobin in g/dL | During the pregnancy and at delivery | |
Secondary | Neonatal hemoglobin at birth | Foetal hemoglobin in g/dL | At the head to toe assessment of the baby within 24 hours of delivery | |
Secondary | Proportion of fetal loss | Early stillbirth < 20-27 completed weeks of pregnancy Late stillbirth 28 -36 weeks of pregnancy Term still birth > 37 weeks of pregnancy | During the study time, for each inclusion until delivery | |
Secondary | Prematurity | Baby born Extremely preterm < 28 weeks of pregnancy Very preterm 28-32 weeks of pregnancy Moderate to late preterm 32-37 weeks of pregnancy | At delivery |
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